FibromyalgiaNCT05395832

Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions in Nature or at Sea

A study testing TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea, TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature and TAU + multicomponent treatment VIRTUAL FIBROWALK in people with Fibromyalgia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The aim of this study was to examine the effectiveness of a video-based multicomponent program: the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) in nature or at sea (FM) compared to Fibrowalk Virtual only. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Fibromyalgia
What is being tested?: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea, TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature and TAU + multicomponent treatment VIRTUAL FIBROWALK
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 siteSpain
Study dates: 25 Apr 2022to 23 Feb 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults from 18 to 75 years-old. 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified - - - ACR diagnostic criteria for fibromyalgia
Able to understand Spanish and accept to participate in the study.

Who cannot join

Participating in concurrent or past RCTs (previous year).
Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Vall Hebron
Barcelona, 08035

Other trials in Spain

About this study

Official title: Effectiveness of Two Video-based Multicomponent Treatments for Fibromyalgia: The Added Value of Face-to-face Sesions in Nature or at Sea in a Three-arm Randomised Controlled Trial

Read the detailed description

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) in comparation of the Fibrowalk virtual plus face-to-face sessions in the nature or at sea.

VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK combines de same components than Fibrowalk Virtual and added 4 face-to-face sessions (1 per mounth) to resolve doubts and reinforce the main concepts of therapy in the nature or at sea.

The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Conditions: Fibromyalgia
Being tested: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea, TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature, TAU + multicomponent treatment VIRTUAL FIBROWALK
Keywords: Fibromyalgia, multicomponent treatment, chronic pain, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial, virtual format
Medical subject headings: Fibromyalgia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at seaBehavioural
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) at sea Standard pharmacological treatment usually provided to patients with fibromyalgia.
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in natureBehavioural
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) in nature Standard pharmacological treatment usually provided to patients with fibromyalgia.
TAU + multicomponent treatment VIRTUAL FIBROWALKBehavioural
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.

Study groups in NCT05395832
Study group	Role	What they receive
TAU + multicomponent treatment VIRTUAL FIBROWALK at sea	Experimental	VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session at sea will be added to solve doubts and emphasize the most important points of therapy Receives: Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea
TAU + multicomponent treatment VIRTUAL FIBROWALK in nature	Active comparator	VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session in nature will be added to solve doubts and emphasize the most important points of therapy Receives: Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature
TAU + multicomponent treatment VIRTUAL FIBROWALK	Active comparator	VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training Receives: Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK

What is being measured

The primary outcome is the main question the study is designed to answer.

Revised Fibromyalgia Impact Questionnaire (FIQR)
The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.
Measured: Through study completion, an average of 3 months

Secondary outcomes (4)

Visual-analogue scale of perceived pain (VAS-Pain)
Patients indicate their pain during the last week on a 10 cm line. Total scores range from 0 to 10, where higher scores indicate a greater pain.
Measured: Through study completion, an average of 3 months
Tampa Scale for Kinesiophobia (TSK-11)
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Measured: Through study completion, an average of 3 months
Hospital Anxiety and Depression Scale (HADS)
HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.
Measured: Through study completion, an average of 3 months
Physical Function of the 36-Item Short Form Survey (SF-36)
Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.
Measured: Through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202223 Feb 2023

First posted27 May 2022
Study start25 Apr 2022
Primary completion25 Sep 2022 (estimated)
Study completion23 Feb 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05395832
Sponsor's protocol ID: FIBROWALK NATURE
Status last verified: Jun 2022
First submitted: 24 May 2022
Last updated: 22 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Two Video-based Multicomponent Treatments for Fibromyalgia: The Added Value of Face-to-face Sesions in Nature or at Sea in a Three-arm Randomised Controlled Trial
ClinicalTrials.gov ID: NCT05395832
Acronym / sponsor ID: FIBROWALK NATURE
Conditions: Fibromyalgia
Keywords: Fibromyalgia, multicomponent treatment, chronic pain, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 109 participants (actual)
Lead sponsor: Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
Collaborators: Universitat Autonoma de Barcelona
Study start: 25 Apr 2022 (actual)
Primary completion: 25 Sep 2022 (estimated)
Study completion: 23 Feb 2023 (estimated)
First posted: 27 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TAU + multicomponent treatment VIRTUAL FIBROWALK at sea	Experimental	Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at seaVIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session at sea will be added to solve doubts and emphasize the most important points of therapy
TAU + multicomponent treatment VIRTUAL FIBROWALK in nature	Active comparator	Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in natureVIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session in nature will be added to solve doubts and emphasize the most important points of therapy
TAU + multicomponent treatment VIRTUAL FIBROWALK	Active comparator	Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALKVIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults from 18 to 75 years-old. 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified - - - ACR diagnostic criteria for fibromyalgia
Able to understand Spanish and accept to participate in the study.

Key exclusion criteria (2 listed)

Participating in concurrent or past RCTs (previous year).
Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at seaGroup treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) at sea Standard pharmacological treatment usually provided to patients with fibromyalgia.	Behavioural	TAU + multicomponent treatment VIRTUAL FIBROWALK at sea
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in natureGroup treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) in nature Standard pharmacological treatment usually provided to patients with fibromyalgia.	Behavioural	TAU + multicomponent treatment VIRTUAL FIBROWALK in nature
TAU + multicomponent treatment VIRTUAL FIBROWALKGroup treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.	Behavioural	TAU + multicomponent treatment VIRTUAL FIBROWALK

Primary outcome

Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Through study completion, an average of 3 months
The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.

4 secondary outcomes

Visual-analogue scale of perceived pain (VAS-Pain)
Time frame: Through study completion, an average of 3 months
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Through study completion, an average of 3 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Through study completion, an average of 3 months
Physical Function of the 36-Item Short Form Survey (SF-36)
Time frame: Through study completion, an average of 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Individual participant dataSharing planned: No

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Revised Fibromyalgia Impact Questionnaire (FIQR) (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05395832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.